Ibandronic acid-Vista film-coated tablets 50 mg blister No. 30




Ibandronic acid-Vista tablets are indicated for:
Prevention of skeletal injuries (pathological fractures, bone lesions requiring radiation therapy or surgical treatment) in patients with breast cancer and metastatic bone lesions.Composition
Active ingredient: ibandronic acid;
1 film-coated tablet contains 50 mg of ibandronic acid in the form of ibandronate sodium monohydrate 56.25 mg;
Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone (type A), colloidal silicon dioxide, sodium stearyl fumarate;
Film coating: (Opadry II white): polyvinyl alcohol, titanium dioxide (E 171), talc), macrogol 3350.
Contraindication
Hypersensitivity to ibandronic acid or any of the other ingredients of the drug. Hypocalcemia. Disease of the esophagus with delayed esophageal emptying, e.g. stricture, achalasia. Inability to remain upright (standing or sitting) for at least 60 minutes.Method of application
The tablets should be swallowed whole with 1 glass of plain water (180-240 ml), while sitting or standing upright. Water with a high calcium concentration should not be used. If there are concerns about potentially high calcium levels in the water (hard water), it is recommended to use bottled water with a low mineral content.
Patients should not lie down for 60 minutes after taking the drug.
The drug should be taken with plain water only.
Patients should not chew or suck the tablet due to the possibility of ulceration of the oropharyngeal mucosa.
Application features
Pregnant women
Not applicable.
Children
Not applicable.
Drivers
Does not affect.
Overdose
There is no specific information on the treatment of overdose with the drug.
However, based on current knowledge of bisphosphonates, upper gastrointestinal adverse reactions (such as gastric upset, dyspepsia, oesophagitis, gastritis, ulcer) or hypocalcaemia may occur. Milk or antacids should be administered to bind the drug, and any adverse reactions should be treated symptomatically. Vomiting should not be induced due to the risk of oesophageal irritation. Patients should be kept in an upright position.
Side effects
On the part of the immune system: rarely - exacerbation of bronchial asthma; rarely - hypersensitivity reactions; very rarely - anaphylactic reactions / shock. On the part of the nervous system: often - headache, sometimes - dizziness. On the part of the organ of vision: rarely - eye inflammation. On the part of the gastrointestinal tract: often - esophagitis, gastritis, gastroesophageal reflux disease, dyspepsia, diarrhea, abdominal pain, nausea; sometimes - esophagitis, including esophageal ulcers or strictures and dysphasia, vomiting, flatulence; rarely - duodenitis. On the part of the skin and subcutaneous tissue: often - rash.Interaction
The oral bioavailability of ibandronic acid is reduced in the presence of food. In particular, calcium-containing foods, including milk, and other polyvalent cations (aluminum, magnesium, iron) may impair absorption of the drug, which is consistent with the results obtained in animal studies. Therefore, the drug should be taken after an overnight fast (at least 6 hours).
Storage conditions
Keep out of reach of children.
Store at a temperature not exceeding 25 °C.
Shelf life - 3 years.
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